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Drug Development

COVID-19 vaccines and antibodies advance even faster than expected

With large vaccine trials planned and monoclonal antibody trials underway, efficacy data could come this fall or winter

by Ryan Cross
June 19, 2020 | APPEARED IN VOLUME 98, ISSUE 24

 

09824-buscon1-regeneron.jpg
Credit: Regeneron
Regeneron's preclinical manufacturing lab, where selected antibodies for preclinical and toxicology studies will be made in stainless steel bioreactors

Early in the COVID-19 pandemic, infectious disease experts said that developing a vaccine for the virus would take at least 12–18 months. Now, in their continued blitzkrieg against SARS-CoV-2, the novel coronavirus that causes COVID-19, several drug companies are keeping pace with their ambitious timelines, and some are moving even faster than they initially predicted.

Three companies with funding from the US government—AstraZeneca, Johnson & Johnson, and Moderna—are on track to distribute the first commercial batches of their experimental vaccines in late 2020 or early 2021. Those firms are top players in Operation Warp Speed, the US plan to have 300 million doses of a safe and effective COVID-19 vaccine by January 2021.

Separately, several groups began clinical trials in June of monoclonal antibodies designed to target and neutralize SARS-CoV-2. Although many older drugs are being repurposed as potential COVID-19 therapies, the antibody trials helmed by Eli Lilly and Company, Regeneron Pharmaceuticals, and Singapore-based Tychan are the first to test drugs created specifically for treating COVID-19.

The pandemic is pushing drug companies to develop and test their wares at unparalleled speeds. “There is no reason you couldn’t speed up drug development if you really focused on it, and that’s what the pandemic has brought,” says Lisa Kennedy, CEO of the life sciences consulting firm Innopiphany.

Never have so many groups been working on vaccines and treatments for the same disease, says Esther Krofah, executive director of FasterCures, a medical research advocacy division of the Milken Institute. “We have to be cautiously optimistic,” Krofah says. “Clinical trials are notorious for not going well.”

Large trials this summer and fall could provide the first evidence that some of the experimental COVID-19 vaccines are working. AstraZeneca, which is developing an adenoviral vector vaccine designed at the University of Oxford, is recruiting 10,000 people in the UK, 30,000 people in the US, and potentially 2,000 people in Brazil for its Phase III study to determine if the vaccine is effective. If the trial is successful, AstraZeneca says, it could start distributing the vaccine as early as September in the UK and October in the US.

Moderna plans to begin a 30,000-person Phase III study of its messenger RNA (mRNA) vaccine in July. The firm is working with the contract manufacturer Lonza to produce 500 million doses or more per year.

And J&J, which like AstraZeneca is developing an adenoviral vector vaccine, says it will begin its first clinical trial in the second half of July—two months earlier than anticipated. The trial will test the vaccine in 1,045 healthy volunteers in the US and Belgium. J&J is also trying to move faster on planning for its larger trials.

The Chinese companies Sinovac and China National Pharmaceutical Group—also known as Sinopharm—are prepping for Phase III studies of their vaccines outside China. Both firms are developing vaccines made from chemically inactivated SARS-CoV-2. They say people receiving their vaccines in Phase II studies developed neutralizing antibodies to the virus, but the data have not been published.

Krofah says monoclonal antibodies could “be a bridge to a vaccine” before vaccines are widely available.

Lilly was the first company to begin clinical trials of monoclonal antibodies, discovered by the Canadian company AbCellera Biologics and the Chinese firm Shanghai Junshi Biosciences. It took only about 90 days from the start of AbCellera’s discovery program to the first injection of the antibody in a clinical trial.

“Typically, that process could take between 1 1/2 to 2 years minimum, so doing it in 3 months is extraordinary,” says Janice Reichert, executive director of The Antibody Society, a trade organization.

Others are also moving fast. Regeneron has begun two clinical trials of an experimental therapy that includes two monoclonal antibodies that target SARS-CoV-2. Tychan says it has begun clinical trials of its antibody in China.

By Reichert’s estimation, there could be upward of 20 SARS-CoV-2 antibody programs in clinical studies by the end of the year, and it should not take long to determine if these drugs are effective. Lilly says it could have data by the end of the summer. “The readout is pretty quick with COVID-19,” Reichert says. “You either get better or you don’t.”

If the clinical trials are successful, vaccine and antibody developers alike have suggested that their products could be available to certain groups through the US Food and Drug Administration’s emergency use authorization (EUA), rather than a formal approval. The FDA announced an EUA for the antiviral drug remdesivir in May, three weeks before data from clinical trials were published.

Vaccines for COVID-19 are likely to first be available through EUA, Krofah says, and she stresses the need for companies to publish data quickly in such a situation. “It is very important that all of the safety and efficacy data is shared and available publicly so that the public has confidence that this is not being hurried,” she says.

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Comments
Crissy Kerr (June 21, 2020 12:20 PM)
Is there any plans to investigate long term health effects before inoculating the entire human population?
Robert Brooks (June 22, 2020 4:27 PM)
Such a thing could not be done with any degree of accuracy without a large sample size and 25+ years of research.
Arthur Meyer (June 22, 2020 10:32 AM)
I wish we could read this type of article (one based on fact and not politics) in the mainstream "newspapers". It is factual and optimistic and not meant to scare or control. A well written and researched article.
Colin (June 23, 2020 8:24 AM)
Presumably any long-term side effects would not be as bad as the short-term effects of having Covid19, namely Death
norbert kelvin (June 25, 2020 1:27 AM)
Mr.Trup might be interested to learn that cannabis is an excellent antidote to COVID-19. This result bears checking out.

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